“Board sets three-tier ‘necessity test’; says dossier compliance check should normally be done first.
Echa’s Board of Appeal (BoA) has annulled an agency Decision on the substance evaluation of carbon tetrachloride.
And the ruling establishes important points about the relationship between the processes of dossier evaluation and substance evaluation.
Carbon tetrachloride is included in the Community rolling action plan (Corap) – the list of chemicals subject to “substance evaluation” under REACH.
Following its evaluation by the French authorities, Echa sent a Decision to the registrants. This required them to conduct an extended one-generation reprotoxicity testing study (Eogrts) to assess its reproductive properties.
Six registrants appealed against the Decision on various grounds, including that:
• the study was disproportionate and unnecessary, because existing data shows that reproductive toxicity only occurs at very high levels of exposure; and
• sufficient regulatory measures are already in place to ensure human health protection
Importantly, the BoA’s ruling says that if Echa wants to request extra information under substance evaluation it must first satisfy a three step test:
• firstly, it must be able to show that there is a potential environmental or health risk – and that such a risk should be one that “occurs in reality and not only theoretically”;
• secondly, it must prove that the potential risk needs to be clarified; and
• thirdly, it must show that the information requested has a realistic possibility of leading to improved risk management measures.
The board’s conclusion was that the evaluating member state (eMS) and Echa failed to meet any of these prerequisites.
On the question of potential risk, the BoA said the only possible exposure to the substance is to workers. This, it said, is managed by an occupational exposure limit – a Dnel based on systemic liver toxicity – and by strict risk management measures (RMMs).
Any reproductive toxicity,it added, would only arise at levels of exposure “well above” the Dnel. The eMS and Echa had failed to rebut the registrants’ claim that the Dnel would also protect workers against reproductive toxicity, or that the existing RMMs would not protect them.
The appellants said Echa asked for the Eogrts because the registration dossier of one of the appellants – the only registrant in the largest annual tonnage threshold of 1,000 tonnes or more, and which therefore had to meet stricter data requirements – did not contain the standard information required by REACH. Instead it included a waiver that Echa considered inadequate.
In its defence the agency confirmed that it believes there is a concern when such standard information is not available in case it is « relevant for the scope of the substance evaluation process”.
But the BoA said the objectives of dossier and substance evaluation are different: “the normal course of action” should be for the agency to conduct a dossier compliance check prior to a substance evaluation. This, it said, should ensure the latter is conducted on the basis of a more complete set of data. Furthermore, one of the prioritisation criteria for selecting dossiers for a compliance check is that the dossier is for a substance listed in the Corap.
Additionally, the BoA said a dossier adaption such as a waiver is specific to a registration and cannot therefore be used as an argument, on its own, for an information request imposed on several registrants as part of a substance evaluation.
“Filling a standard information requirement through substance evaluation could lead to significant costs for low tonnage and intermediate registrants who would not be exposed to such costs if the standard information had been provided through a registration by a higher volume registrant,” said the BoA. Therefore, this should not be done “without clear justification” – for example, if there is an immediate, relevant and real concern” for health or the environment.
Jean-Philippe Montfort of Mayer Brown, who defended the case, said it has broad implications because of the threshold it sets for Echa to meet to justify its requests for information in substance evaluation cases.
“The burden of proving that the conditions of this three-tier `necessity test’ are met is clearly on the agency and the justification must be clearly spelled out in an Echa Decision.”
Article by Geraint Roberts
BoA decision : http://echa.europa.eu/documents/10162/b224dd5a-03a8-40a6-9e42-42b3e56a8c74
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